V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE— 510(k) K093408

Clearance details

Applicant

Surgical Devices, A Division of Tyco Healthcare

Product code

Code GAM

Device class

Class 2

Regulation

21 CFR 878.4493

Advisory panel

General, Plastic Surgery

Date received

2009-11-02

Decision date

2009-11-12

Decision

Substantially Equivalent

Clearance type

Special

Location

North Haven, CT, US

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• K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device2025-12-22
• K253620 — TroClose 12002025-12-16

• K100257 — VLOC9ABSORBABLE WOUND CLOSURE DEVICE2010-05-10
• K100242 — AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER2010-02-17

Death

45

Injury

5,711

Malfunction

30,744

Other

4

Total

36,504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2919-2026 — V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SIGNIA BOX02191V11 BOX GASTRICBYPASS KIT V4 BOX06863V4 BOX GB BOX MET LHOOK PST04884V3 BOX GB ZONDER ENDOHERNIA EGIA PST04884V6 BOX GBP SIGNIA BOX08506V2 BOX KIT COLON IHS KIT00625V1 BOX KIT HERNIA HIATO IHS KIT01026V1 BOX LAP HERNIE INGUNIAL RIGHT BOX00051V4 BOX NEW GBP KIT PST03130V2 BOX ZESTAW DO BARIATRII GB UCKGB5 BOX ZESTAW DO RYGB WEJRYGB3 VLOCL0013 V-LOC* 180 4-0 CLR 30CM P12 VLOCL0013 VLOCL0014 V-LOC* 180 3-0 CLR 30CM P12 VLOCL0014 VLOCL0023 V-LOC* 180 4-0 CLR 45CM P12 VLOCL0023 VLOCL0024 V-LOC* 180 3-0 CLR 45CM P12 VLOCL0024 VLOCL0306 V-LOC 180 DEVICE 0 15CM GS-21 VLOCL0306 VLOCL0316 V-LOC* 180 0 GRN 30CM GS21X12 VLOCL0316 VLOCL0345 V-LOC* 180 2-0 GRN 23CM GS21 VLOCL0345 VLOCL0436 V-LOC* 180 0 GRN 60CM GS25X12 VLOCL0436 VLOCL0604 V-LOC* 180 3-0 GRN 15CM V20 VLOCL0604 VLOCL0615 V-LOC* 180 2-0 GRN 30CM V20 VLOCL0615 VLOCL0625 V-LOC* 180 2-0 GRN 45CM V20 VLOCL0625 VLOCL0644 V-LOC* 180 3-0 GRN 23CM V20 VLOCL0644 VLOCL0804 V-LOC 180 3-0 GRN 15CM CV23 VLOCL0804 VLOCL2105 V-LOC* 180 2-0 GRN 15CM GS22 VLOCL2105 VLOCL2145 V-LOC* 180 2-0 GRN 23CM GS22 VLOCL2145 VLOCL2246 VLOC180 0 GRN 9 GS-22 VLOCL2246Class II·Ongoing·Covidien, LP·20260624

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093408.